Job Title: Quality Engineer II (Complaints)
Reports to: Senior Quality Engineer &ndash; Complaints
Contract: 12-month contract (hybrid)
Salary - 3 days onsite
Overview
An opportunity is available for a Quality Engineer to join a complaints investigation team within a cardiovascular medical device function. The role focuses on supporting investigations, ensuring high-quality complaint handling, and contributing to continuous improvement initiatives within a growing business area.
Purpose of the Role
Provide Quality Engineering support to the complaint investigation process, ensuring high standards in investigation quality, regulatory compliance, and adherence to quality systems, with a strong focus on patient safety and product quality.
Key Responsibilities
<ul>
<li>Review and approve complaint investigations within a global complaints management system</li>
<li>Conduct complaint investigations, including lab testing of returned devices where required</li>
<li>Perform root cause analysis and define appropriate investigation pathways</li>
<li>Analyse product and process performance using data analytics tools</li>
<li>Prepare and present complaint trend data to relevant review forums</li>
<li>Drive continuous improvement in investigation methods and processes</li>
<li>Make decisions on escalation pathways and work independently when required</li>
<li>Ensure compliance with all applicable quality system regulations</li>
<li>Collaborate with cross-functional teams including Quality, R&amp;D, Operations, and Field Support</li>
</ul>
Requirements
<ul>
<li>Level 8 qualification in a STEM discipline with 2&ndash;3 years&rsquo; relevant experience</li>
<li>Medical Device Experience 3+ years&nbsp;</li>
<li>Strong problem-solving, process improvement, or project management skills</li>
<li>Ability to take initiative and drive improvements</li>
<li>Knowledge of product design, manufacturing, or clinical use (advantageous)</li>
<li>Strong analytical, communication, and organisational skills</li>
<li>Ability to work both independently and within a team</li>
<li>Experience with imaging review (advantageous)</li>
</ul>
Willingness to complete required health and safety training for handling returned products

Quality Engineer II

Purpose:
We are seeking a motivated and innovative Engineer to join our clients Design Assurance Lab team, supporting the development, validation, and continuous improvement of test methods, equipment, and laboratory processes within a regulated environment. The successful candidate will play a key role in the design and validation of test hardware, software, fixtures, and tooling, while collaborating cross-functionally with New Product Development and Operating Units to ensure best practices and consistency across projects. This role offers the opportunity to contribute to cutting-edge technology initiatives, drive problem-solving activities, and support the delivery of high-quality, compliant testing solutions in a fast-paced and collaborative environment.
Responsibilities:
<ul>
<li>Support the Design Assurance Lab in introducing test methods and their associated test hardware and software.</li>
<li>Responsible for the design, procurement, development and validation of equipment, fixtures, and tooling used in the lab.</li>
<li>Create basic test scripts or software programs that help automate test processes.</li>
<li>Collaborate and align with Operating Unit&rsquo;s and New Product Development projects on Test Method best practices and strategies to ensure consistency in approach.</li>
<li>Identify new equipment and technology development initiatives that will drive continuous improvement within the lab.</li>
<li>Lead and support root cause investigations relating to test issues &amp; drive problem solving efforts.</li>
<li>Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.</li>
<li>You will liaise with projects to facilitate timely completion of Test Method Validation activities.</li>
<li>Support team members on execution of project deliverables and co-ordinate all relating activities</li>
</ul>
Key Skills &amp; Experience
<ul>
<li>Minimum of Degree level 8 in Engineering / Science or related discipline with a minimum of 2 years of relevant experience.</li>
<li>Experience working in the medical device or other regulated industry.</li>
<li>Experience of equipment design, verification &amp; validation in medical device or other regulated industry are desirable. (IQ, OQ, etc.)</li>
<li>Experience with CAD is desirable.</li>
<li>Ability to identify and resolve issues without direct supervision.</li>
<li>Dynamic team player and can work effectively and proactively across multiple projects</li>
<li>Ability to lead and mentor up and coming engineers instilling best practices.</li>
<li>Good communicator and fluent in English, with a high level of enthusiasm and motivation.</li>
<li>Good organizational, presentation and project management skills are desirable.</li>
</ul>

Test Equipment Engineer II

Quality/Design Assurance Engineer (12-Month Contract)
Fully onsite
You will act as an extended team member on a PDP Project, representing the Design Assurance function and reporting indirectly to the Quality Lead on the project.
Key Responsibilities
<ul>
<li>Prepare test method validations, design verification, and shelf-life protocols/reports.</li>
<li>Maintain up-to-date knowledge of industry best practices related to product design.</li>
<li>Ensure expert understanding of regulatory compliance requirements across product design, development, transfer, and commercialisation activities.</li>
<li>Collaborate cross-functionally, both internally and externally, to build strong working partnerships.</li>
<li>Provide Quality input into new product development, process improvements, and change control activities.</li>
<li>Support cross-functional teams in designing protocols to ensure new products or product changes are appropriately evaluated and tested in line with applicable standards.</li>
</ul>
Requirements
<ul>
<li>Bachelor&rsquo;s degree (Level 8 NFQ) in a relevant technical discipline such as Engineering or Science.</li>
<li>Minimum 2 years&rsquo; relevant industry experience.</li>
<li>Ability to work independently with general supervision on moderately complex projects and assignments.</li>
<li>Strong team collaboration skills with experience contributing effectively across cross-functional teams.</li>
<li>Experience in medical device product design is required.</li>
<li>Excellent communication and influencing skills.</li>
<li>Fluent English, both written and spoken.</li>
</ul>

Design Quality Engineer &ndash; 12 Month FTC
Overview
Our client, a leading multinational medical device organisation, is seeking a Design Quality Engineer to support their Design Quality team on a 12-month fixed-term contract. This role will focus on product risk management, quality engineering support for new product development activities, and ensuring compliance with applicable regulatory and quality standards within a highly regulated environment.
This is an excellent opportunity for an experienced Quality Engineer with strong medical device experience to join a collaborative and fast-paced manufacturing environment.
Key Responsibilities
<ul>
<li>Ensure compliance with all applicable regulatory requirements, standards, and internal quality procedures</li>
<li>Support Quality Engineering activities across New Product Development (NPD) and New Product Introduction (NPI) programs</li>
<li>Provide support for:</li>
<ul>
<li>Test method validation</li>
<li>Product verification &amp; validation</li>
<li>Reliability testing</li>
<li>Statistical data analysis</li>
</ul>
<li>Support component qualification, process capability studies, equipment qualification, and process validation activities</li>
<li>Maintain and support product risk management files in line with ISO 14971 requirements</li>
<li>Participate in field assurance investigations and post-market surveillance activities</li>
<li>Collaborate closely with R&amp;D and Engineering teams to support successful product launches and lifecycle management</li>
<li>Review and approve validation documentation and risk management records</li>
<li>Participate in internal, external, and regulatory audits</li>
<li>Support regulatory submissions and continuous improvement initiatives</li>
</ul>
Candidate Requirements
Qualifications
<ul>
<li>Third-level qualification in Engineering, Science, or a related technical discipline</li>
<li>Minimum 3+ years&rsquo; experience within the medical device industry (Class II or III preferred)</li>
<li>Experience working within a highly regulated environment such as medical devices, pharmaceutical, or life sciences</li>
</ul>
Technical Experience
<ul>
<li>Strong understanding of:</li>
<ul>
<li>ISO 13485</li>
<li>ISO 14971</li>
<li>MDR/MDD</li>
<li>MDSAP</li>
<li>QSR / 21 CFR</li>
<li>Applicable regulatory and quality standards</li>
</ul>
<li>Hands-on experience with:</li>
<ul>
<li>Design validation</li>
<li>Process validation</li>
<li>Equipment qualification</li>
<li>Test method validation</li>
<li>Risk management</li>
</ul>
<li>Experience supporting NPD/NPI and product commercialisation activities</li>
<li>Experience participating in quality and regulatory audits</li>
</ul>
Skills &amp; Competencies
<ul>
<li>Strong analytical and problem-solving skills</li>
<li>Excellent communication and stakeholder management abilities</li>
<li>Ability to work effectively in a fast-paced environment</li>
<li>Self-motivated with a proactive and collaborative approach</li>
<li>Strong organisational skills with the ability to manage multiple priorities</li>
<li>Continuous improvement mindset</li>
</ul>
If you are interested in learning more about this opportunity, please apply with your updated CV.
&nbsp;

Design Quality Engineer - 12 month FTC

<p style="color: #242424; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;" data-olk-copy-source="MessageBody">Process Technician - Weekend Shift&nbsp; The role is within the balloon manufacturing area and I am looking for the following expertise:
<ul style="color: #242424; font-family: 'Segoe UI', 'Segoe UI Web (West European)', -apple-system, BlinkMacSystemFont, Roboto, 'Helvetica Neue', sans-serif; font-size: 15px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; margin-top: 0px; margin-bottom: 0px;" type="disc">
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Someone with previous experience as a process/manufacturing technician</li>
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Someone with equipment troubleshoot/repair experience</li>
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Someone with Mechanical/pneumatic/electrical experience</li>
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Someone with strong process troubleshooting experience (troubleshooting settings/materials/equipment to reduce scrap)</li>
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Medical device experience desirable</li>
<li style="font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">Polymer processing knowledge also desirable.</li>
</ul>
<p style="color: #242424; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">&nbsp;
<p style="color: #242424; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-size: 12pt; font-family: Aptos, sans-serif; margin: 0px;"><span style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Calibri, sans-serif; font-optical-sizing: inherit; font-size-adjust: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; font-language-override: inherit; margin: 0px; padding: 0px; vertical-align: baseline; color: inherit;">&nbsp;

Process Technician - Weekends

Job Purpose:The Senior Process Development Engineer will lead the development, characterisation, validation, and industrialisation of electronics-enabled manufacturing processes for catheter-based medical devices.This role requires strong electronics and PCB integration expertise, combined with demonstrated technical leadership and mentoring of engineers in a regulated medical device environment.Key Responsibilities:Process Development &amp; Electronics Integration<ul><li>Lead development and optimisation of electronics-related manufacturing processes for catheter systems, including PCB, flex circuits, wire assemblies, sensors, and electrodes.</li><li>Provide technical leadership on PCB and electronics integration into catheter assemblies, including DFM/DFA input to R&amp;D.</li><li>Partner with suppliers on PCB fabrication, electronics assembly, and component qualification.</li></ul>Validation, Quality &amp; Compliance<ul><li>Own and execute Process Validation (IQ/OQ/PQ) and Test Method Validation activities.</li><li>Author and approve PD documentation including PCs, PRAs, MVPs, MIs, and validation reports.</li><li>Ensure compliance with ISO 13485, FDA QSR, and internal quality systems.</li></ul>Manufacturing Support &amp; Continuous Improvement<ul><li>Act as escalation point for electronics-related manufacturing issues, leading root cause investigations and corrective actions.</li><li>Drive process robustness, yield improvement, and reliability enhancements.</li></ul>Technical Leadership &amp; Mentoring<ul><li>Mentor and technically develop junior and mid-level engineers within the Process Development organisation.</li><li>Provide technical direction and coaching on electronics-related process challenges.</li><li>Lead or co-lead PD workstreams, setting technical strategy and standards.</li><li>Act as a subject matter expert (SME) for electronics processes within catheter programs.</li></ul>Education &amp; Experience:<ul><li>Level 8 Hons Bachelor Degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or related discipline.</li><li>7+ years experience in Process Development / Manufacturing Engineering within medical devices or another regulated industry.</li><li>Demonstrated hands-on experience with electronics-enabled medical devices, ideally catheter-based systems.</li><li>Direct experience with electrophysiology, diagnostic, or therapeutic catheters.</li><li>Strong experience in PCB design and/or PCB integration (rigid and/or flex).</li></ul>o	Experience with flex circuits, embedded electronics, sensors, or high-voltage signal systems.o	Supplier management experience for outsourced PCB or electronics manufacturing.<ul><li>Exposure to regulatory submissions, audits, or design reviews.</li></ul><ul><li>Experience leading PD engineers or technicians in a formal role.</li><li>Familiarity with statistical tools (DOE, Minitab, capability analysis).</li><li>Experience supporting NPI through pilot and commercial launch.</li><li>Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk management activities.</li><li>Experience authoring and approving regulated technical documentation (PCs, PRAs, MIs, validation reports).</li><li>Demonstrated mentoring or technical leadership experience (formal or informal).</li><li>Strong structured problem-solving and data-driven decision-making skills.</li><li>Ability to work cross-functionally with R&amp;D, Quality, Manufacturing, and Suppliers.</li></ul>

Job Details

Quality Engineer II